Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain

Pain, Chronic Clinical Trial

— SENSE SCS  

Official title:

Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS Clinical Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775510
• Other study ID #: MDT22020
• Status: Recruiting
• Start date: March 30, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: MedtronicNeuro
• Contact: Study Inbox
• Phone: 763-514-4000
• Email: rs.sensescsstudy[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Medtronic, Inc. is sponsoring the SENSE SCS clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (PROs). The purpose of the study is to evaluate workflow of a mobile application for collection of PROs and to gather data on patient experience with spinal cord stimulation therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: March 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Pilot Phase Inclusion Criteria:

1. 18 years of age or older

2. A clinical decision was made for the patient to receive a commercial Medtronic SCS system (trial and implant) limited to the components for an on-label indication prior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact and Specify™SureScan™ MRI 2x8 leads are not eligible system components

3. Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee

4. Willing and able to use a personal smart phone for study surveys. NOTE: All subjects participating in the study must be willing to download the InsightPro™ clinical trial app and maintain current software updates on their own smart phone.

5. Willing and able to provide signed and dated informed consent in English

6. Willing and able to comply with all study procedures and visits

Pilot Phase Exclusion Criteria:

1. Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)

2. Currently participating, or plans to participate, in another investigational study or has a planned major medical procedure that may interfere with study procedures or confound study results, as determined by the Investigator or designee, unless documented pre-approval is provided by the sponsor

3. Major untreated or refractory psychiatric comorbidity or other progressive disease (e.g., neurodegenerative disease, heart failure, cancer) that may confound study results, as determined by the Investigator or designee

4. Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee

5. Pregnant or planning on becoming pregnant

6. Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation

7. Patients with buried lead trials/implants will be excluded from this study

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Intractable

Intervention

Device:
• Commercially available neurostimulation systems
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems

Locations

Country	Name	City	State
United States	Coastal Research Institute	Carlsbad	California
United States	Garden State Pain and Orthopedics	Clifton	New Jersey
United States	Twin Cities Pain Clinic	Edina	Minnesota
United States	Pain Management Consultants of Southwest Florida	Fort Myers	Florida
United States	North Texas Orthopedics and Spine Center	Grapevine	Texas
United States	Oklahoma Pain Management	Oklahoma City	Oklahoma
United States	The San Antonio Orthopaedic Group	San Antonio	Texas
United States	Procura Pain and Spine PLLC	Shenandoah	Texas
United States	Novant Health Spine Specialists	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.	The percentage of surveys with complete data collected via the InsightPro™ clinical trial app from Baseline through the SCS Trial Period, calculated as the number of surveys with complete data divided by the total number of expected surveys within the Pilot Phase Cohort, expressed as a percentage.	Up to 28 days
Primary	Rating on the 7-point scale of Patient Global Impression of Change (PGIC) at Month 3 in the Data at Scale Phase Cohort	PGIC is a single question asking the subject to rate their improvement in pain condition on a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse)	Month 3